Efficacy of Manual Therapy in Migraine (MTHDIQMi)
Primary Purpose
MIGRAINE
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Sternocleidomastoid MTRP and stretching
Trapezius MTRP and stretching
Sponsored by
About this trial
This is an interventional treatment trial for MIGRAINE focused on measuring efficacy, manual therapy, migraine, quality of life
Eligibility Criteria
Inclusion Criteria:
- Patients were diagnosed according to the criteria established by the IHS
Exclusion Criteria:
- Patients were excluded if they presented with other headache types, if their headache was triggered by neck movement, or if they presented with dizziness, hypertension, emotional stress, psychological disorders, cardiovascular disease or pregnancy.
Sites / Locations
- Gemma v. Espí López
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sternocleidomastoid MTRP and stretching
Trapezius MTRP and stretching
Arm Description
The sternocleidomastoid was treated with ischemic compression.
The central MTRP of the trapezius was treated as described above for the sternocleidomastoid.
Outcomes
Primary Outcome Measures
Pain intensity
The Visual Analogue Scale (VAS)25 was used to rate the patients average pain intensity using a 0-10 scale (0=no pain, 10=the most severe pain).
Secondary Outcome Measures
The impact of headache (HIT-6)
The Headache Impact Test (HIT-6) (Yang et al., 2011) provides an overall measure of the adverse impact of headaches. This questionnaire consists of 6 items measuring the impact of pain on social functioning, role functioning, vitality, cognitive functioning and psychological distress, and provides a measure of the severity.
Disability (MIDAS)
. Disability caused by migraine was assessed by the MIDAS questionnaire (Adenis Silva et al., 2008) based on 5 questions and the score obtained from the sum of the days lost due to headaches registered in the questions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02446275
Brief Title
Efficacy of Manual Therapy in Migraine
Acronym
MTHDIQMi
Official Title
DO SOFT TISSUE TECHNIQUES HAVE A POSITIVE EFFECT ON DISABILITY AND QUALITY OF LIFE IN MIGRAINE SUFFERERS?: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objective: The aim of this study was to determine the efficacy of suboccipital inhibitory manual therapy treatment in migraine compared to treatment based on Myofascial Trigger Points (MTrPs) and their stretching, often being hypersensitive in patients with migraine.
Material and methods: 27 patients in two groups participated in the study: a) the control group received combined techniques based on MTrPs and bilateral stretching in the trapezius and sternocleidomastoid muscle (SCM); b) the experimental group was applied the same techniques as those applied in the control group plus suboccipital inhibition. The treatment lasted for 8 weeks and the impact, disability and quality of life were assessed in both groups.
Detailed Description
Introduction Migraine is a highly prevalent disorder entailing substantial costs. Manual therapy offers an attractive option as an alternative to medical treatment or used in combination therewith. Treatment focused on the soft tissues of the suboccitpital region has been studied in other types of headaches but not in migraine.
Objective: The aim of this study was to determine the efficacy of suboccipital inhibitory manual therapy treatment in migraine compared to treatment based on Myofascial Trigger Points (MTrPs) and their stretching, often being hypersensitive in patients with migraine.
Material and methods: 27 patients in two groups participated in the study: a) the control group received combined techniques based on MTrPs and bilateral stretching in the trapezius and sternocleidomastoid muscle (SCM); b) the experimental group was applied the same techniques as those applied in the control group plus suboccipital inhibition. The treatment lasted for 8 weeks and the impact, disability and quality of life were assessed in both groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MIGRAINE
Keywords
efficacy, manual therapy, migraine, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sternocleidomastoid MTRP and stretching
Arm Type
Experimental
Arm Description
The sternocleidomastoid was treated with ischemic compression.
Arm Title
Trapezius MTRP and stretching
Arm Type
Experimental
Arm Description
The central MTRP of the trapezius was treated as described above for the sternocleidomastoid.
Intervention Type
Other
Intervention Name(s)
Sternocleidomastoid MTRP and stretching
Intervention Description
The sternocleidomastoid was treated with ischemic compression. The patient's head was passively moved into contralateral rotation and the patient was asked to relax completely. Sustained pressure was then applied to the sternocleidomastoid muscle until the pain threshold was reached. During the application of pressure, pain decreases so the pressure was gradually increased over a duration of 1 minute. The pressure was then reduced progressively.
Intervention Type
Other
Intervention Name(s)
Trapezius MTRP and stretching
Intervention Description
The central MTRP of the trapezius was treated as described above for the sternocleidomastoid. Subsequently stretching was performed, whereby the therapist supported the patient's head and performed passive contralateral inclination and ipsilateral rotation of the head. The therapist placed one hand over the patients shoulder while the other hand performed the stretching and simultaneously controlled the position of the head to achieve suitable stretching
Primary Outcome Measure Information:
Title
Pain intensity
Description
The Visual Analogue Scale (VAS)25 was used to rate the patients average pain intensity using a 0-10 scale (0=no pain, 10=the most severe pain).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The impact of headache (HIT-6)
Description
The Headache Impact Test (HIT-6) (Yang et al., 2011) provides an overall measure of the adverse impact of headaches. This questionnaire consists of 6 items measuring the impact of pain on social functioning, role functioning, vitality, cognitive functioning and psychological distress, and provides a measure of the severity.
Time Frame
4 weeks
Title
Disability (MIDAS)
Description
. Disability caused by migraine was assessed by the MIDAS questionnaire (Adenis Silva et al., 2008) based on 5 questions and the score obtained from the sum of the days lost due to headaches registered in the questions.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients were diagnosed according to the criteria established by the IHS
Exclusion Criteria:
Patients were excluded if they presented with other headache types, if their headache was triggered by neck movement, or if they presented with dizziness, hypertension, emotional stress, psychological disorders, cardiovascular disease or pregnancy.
Facility Information:
Facility Name
Gemma v. Espí López
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
24264721
Citation
Fernandez-de-las-Penas C, Dommerholt J. Myofascial trigger points: peripheral or central phenomenon? Curr Rheumatol Rep. 2014 Jan;16(1):395. doi: 10.1007/s11926-013-0395-2.
Results Reference
background
PubMed Identifier
17986274
Citation
Becker C, Brobert GP, Almqvist PM, Johansson S, Jick SS, Meier CR. Migraine incidence, comorbidity and health resource utilization in the UK. Cephalalgia. 2008 Jan;28(1):57-64. doi: 10.1111/j.1468-2982.2007.01469.x. Epub 2007 Nov 6.
Results Reference
background
PubMed Identifier
16618340
Citation
Calandre EP, Hidalgo J, Garcia-Leiva JM, Rico-Villademoros F. Trigger point evaluation in migraine patients: an indication of peripheral sensitization linked to migraine predisposition? Eur J Neurol. 2006 Mar;13(3):244-9. doi: 10.1111/j.1468-1331.2006.01181.x.
Results Reference
background
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Efficacy of Manual Therapy in Migraine
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